Posted 05 July 2016
By Steven Dowdley, Chet Shemanski
This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise.
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Categories: Drugs, Regulatory strategy, Submission and registration, Features, US, Canada, Europe, Japan, FDA
Tags: eCTD, Electronic Submissions, Common Technical Document